Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-6935

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0059793 (Report 446263)

Registrant Name (Full Legal Name no abbreviations): Bayer inc

Address: 2920 Matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L5W5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

13-SEP-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-155

Product Name: Seresto Large Dog

• Active Ingredient(s)
  • FLUMETHRIN
  • IMIDACLOPRID
    • Guarantee/concentration 10 %

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7. b) Type of formulation.

Other (specify)

COLLAR

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: Collar

10. Site pesticide was applied to (select all that apply).

Site: Animal / Usage sur un animal domestique

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

On 09-Sep-2017, an 8 year old, 25 pound, intact, male, West Highland White canine, in unknown condition, with no known concomitant medical conditions, had one Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

West Highland White Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

11.34

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Diarrhea
  • Symptom - Vomiting

• General
  • Symptom - Lethargy

• Skin
  • Symptom - Hair loss

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On 10Sep2017, the canine developed application site alopecia, lethargy, vomiting, and diarrhea. The canine has not been evaluated by a veterinarian and the signs continued. On 11Sep2017, the collar was removed. On approximately 15Sep2017, the canine died.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

O-Unassessable: Reported application site alopecia may occur in sensitive animal after product application. It is usually mild and transient. Reported digestive disorders are unspecific and may have multiple other causes (e.g. gastrointestinal infection, dietary incompatibility). Lethargy is unspecific and may have numerous other causes. In this case sign may be associated with reported digestive disorders. Reported death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause such serious signs either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious sign. Though time to onset is consistent for initially reported application site disorder, lethargy and gastrointestinal disorders, it is long for death. Apart from that, collar had been already removed for several days before the pet died. Considering known safety profile of the product, a product relation is deemed rather unlikely with the death. Considering all reported adverse signs, the case was considered unassessable.